DETAILED ACTION
This office action is in response to applicant’s filing dated November 10, 2025.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of claims
Claims 1, 3, 5, 8, 9 and 12 - 26 are pending in the instant application. Acknowledgment is made of Applicant’s amendments filed November 10, 2025. Acknowledgment is made of Applicant’s cancelation of claims 2, 4, 6-7, 10- 11 and 27-28.
Election/Restrictions
Applicant’s election without traverse of compound K7 of structure
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as a single species in the reply filed on November 10, 2025 is acknowledged.
Claims 3, 5, 8, 12 – 18 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on November 10, 2025.
Claims 1, 9, 19 and 21 – 26 are presently under examination as they relate to elected species compound K7.
Priority
The present application is a 371 of PCT/US2021/045877, filed August 13, 2021 and claims the benefits of priority to U.S. Provisional Application No. 63/065,026, filed August 13, 2020.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 02/10/2023 and 03/24/2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Drawings
Acknowledgement is made of the drawings received on February 10, 2023. These drawings are accepted.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 22 and 24 – 26 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating melanoma, colorectal and lung cancer with compounds: DABK, K5, K6, K7, K8, K9, and K10, does not reasonably provide enablement for treatment of all types of cancer encompassed by instant claims with all variety of compounds encompassed by formula (I). The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. The treatment of cancer generally cannot possibly be considered enabled. This is a scope of enablement rejection.
To be enabling, the specification of the patent application must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fd. Cir. 1993). Explaining what is meant by "undue experimentation," the Federal Circuit has stated that:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996). As pointed out by the court in /n re Angstadt, 537 F.2d 498 at 504 (CCPA 1976), the key word is "undue", not "experimentation".
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 wherein, citing Ex parte Forman, 230 USPQ 546 (Bd. Apls. 1986) at 547 the court recited eight factors:
1- the quantity of experimentation necessary,
2- the amount of direction or guidance provided,
3- the presence or absence of working examples,
4- the nature of the invention,
5- the state of the prior art,
6- the relative skill of those in the art,
7- the predictability of the art, and
8- the breadth of the claims
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
Nature of the invention and the Breadth of the claims.
The invention is drawn to a method for treating different types of cancer recited by claims with all compounds of formula (I)
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, where Y is
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and Z is
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. The breadth of the claims is extensive.
Scope of the compound covered:
The number of compounds encompassed by the formula above is vast since the formula encompasses a large number of possible structural components for each variable of the compound of formula (I) and as such combinations of the various variables recited in the claims would yield millions of compounds.
The formula contains 7 different R groups combination plus variety of structures of elements A and Z. Each of these variables are defined to be any one of the many different moieties, for e.g.:
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.
These compounds encompass molecules that widely vary in the physical and chemical properties such as size, molecular weight, acidity, basicity, and properties that are known in the art to greatly influence pharmacokinetic and pharmacodynamics parameters, not to mention the ability to productively bind to claimed biological target molecules. The claims cover compounds easily in the millions given the number of possible rings, ring systems covered by the claims' scope along with varying choices for remaining variables. Each of these compounds is claimed to be useful in the method of treating all types of cancer, encompassed by instant claims.
Scope of the diseases covered:
The different types of cancer to be treated by the method of invention are: melanoma, thyroid cancer, hairy cell leukemia, ovarian cancer, lung cancer, pancreatic, prostate, gastric, endometrial, glioblastomas, astrocytomas, or colorectal cancer. The scope of disease is vast and vary considerably as detailed below:
Cancer is not a single disease, or cluster of closely related disorders, they have in common only some loss of controlled cell growth. Cancers are highly heterogeneous at both the molecular and clinical level. Different cancers, driven by the same mutation can show different response to the same class of drugs or even to the same individual drug, targeting mutation.
2. The relative skill of those in the art.
The relative skill of those in the art is high, generally that of an M.D. or Ph.D. The artisan using Applicant’s invention would generally be a physician with a M.D. degree and several years of experience. However, given the state of the art as set forth above, the artisan is currently unaware of any one particular anticancer agent that is effective against all cancer cell types.
3. The predictability or unpredictability of the art and the state of the prior art.
The present claims relate to the mechanism underlying the treatment of the claimed diseases with the compounds of the instant invention. Although the discovery of such a mechanism may be an important piece of scientific knowledge, it still needs to be turned into a practical application in the form of a specified actual treatment of the pathological conditions. The factor is outweighed, however, by the unpredictable nature of the art. It is well established that “the scope of enablement varies with the degree of unpredictability of the factors involved” and physiological activity is considered to be an unpredictable factor. See In re Fisher, 166 USPQ 18, at 24 (In cases involving unpredictable factors, such as most chemical reactions and physiological activity, the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved); Nationwide Chemical Corporation, et. al. v. Wright, et. al., 192 USPQ 95 (one skilled in chemical and biological arts cannot always reasonably predict how different chemical compounds and elements might behave under varying circumstances); Ex parte Sudilovsky 21 USPQ2d 1702 (Applicant’s invention concerns pharmaceutical activity. Because there is no evidence of record of analogous activity for similar compounds, the art is relatively unpredictable); In re Wright 27 USPQ2d 1510 (the physiological activity of RNA viruses was sufficiently unpredictable that success in developing specific avian vaccine was uncertain). As illustrative of the state of the art, the examiner cites: Schreck et al (Cancers (Basel). 2019 Aug 28;11(9):1262), Crispo et al (Cancers (Basel). 2019 Sep 18;11(9):1388) and Degirmenci et al (Cancer Drug Resist 2021;4:665-83).
With regards to unpredictability, Schreck, cited for evidentiary purpose teaches: BRAF mutations have been identified as targetable, oncogenic mutations in many cancers. Sensitivity to RAF and MEK inhibitors varies among BRAF mutations and between tumor types as only class I BRAF V600 mutations are sensitive to clinically available RAF inhibitors. While class II and III BRAF mutations are found in primary brain tumors, further research is necessary to determine their sensitivity to third-generation RAF inhibitors and/or MEK inhibitors (abstract). Glioblastoma in adults have BRAF V600E mutations only infrequently (~3%). The effect of BRAF V600E mutations on the clinical course of GBM in adults is unclear and has not been sufficiently studied to date, primarily given the rarity of these tumors. The sensitivity of adult glioma to RAF inhibitors is not as well-defined as in pediatrics. In a basket study of vemurafenib in adults with BRAF V600E-mutated gliomas, the response rate of adults with PXA was high (43%; 3/7) and similar to pediatric patients, but the response rate in GBM and anaplastic astrocytoma was much lower at 9% (1/11) (page 9, 4.3). Schreck further teaches that despite the success of RAF/MEK inhibitor combination therapy in pediatric glioma, some tumors are nonresponders or develop resistance over time to targeted therapy (page 10, §5). Summarizing the review Schreck recommends limiting the use of RAF/MEK inhibitors to the setting of a clinical trial, but combination therapy may represent a viable treatment option for patients with BRAF V600-mutated recurrent glioma who are not eligible for trial. For class II or III mutations, including BRAF-fusions, preclinical data and data in other cancers clearly support the inefficacy of type I RAF inhibitors. Whether BRAF mutations are present in all cells in a glioma or only a subset of tumor cells remains controversial and certainly has the potential to affect tumor response to targeted therapy. In addition, the effects of co-occurring mutations on tumorigenicity and sensitivity to targeted therapy remain to be more fully explored in brain tumors. In summary, knowledge of the specific BRAF mutation and its biochemical effects on ERK signaling are critical for determining whether a patient could benefit from RAF-targeted therapy (page 11, conclusion).
Furthermore, with regards to unpredictability, Crispo, cited for evidentiary purposes, teaches that thyroid carcinomas (TCs) bearing BRAF mutations represent approximately 29–83% of human thyroid malignancies and are less sensitive to BRAF inhibitors and develop primary or acquired resistance due to mutational events or activation of alternative signaling pathways able to reactivate ERK signaling (abstract). The EMA approval of vemurafenib and dabrafenib is still restricted to BRAFV600E-mutated melanoma, since their clinical benefit in thyroid cancer patients was not considered reasonable compared to the toxicity profile (page 5, 4th paragraph). It should be noted that clinical data, which allowed the approval of BRAFi in TC, were obtained mostly in phase 2 trials based on a limited numbers of patients, which represents a major limit for the wide use of these agents. Furthermore, besides the achievement of interesting rates of objective responses upon vemurafenib or dabrafenib single agent therapy, numerous thyroid cancer patients display rapid disease progression due to primary or acquired drug resistance (page 9, conclusion).
Moreover, with regards to unpredictability, Degirmenci, cited for evidentiary purposes, teaches: “In recent years, cancer genomic studies have revealed that genetic alterations that aberrantly activate the RAS/RAF/MEK/ERK signaling mainly occur on RAF or upstream, which motivated the extensive development of RAF inhibitors for cancer therapy (abstract). Targeting hyperactive RAS/RAF/MEK/ERK signaling with RAF inhibitors has achieved promising outcomes for treating cancers harboring BRAF(V600E) mutation. However, both intrinsic and acquired resistance have severely restricted their applications in cancer therapy. With a deeper understanding of regulatory mechanisms of RAF family kinases, next-generation RAF inhibitors that target allosteric sites on kinases and thus have longer efficacy, broader coverage, and fewer off-target effects are being developed, which sheds a light on overcoming emerging drug resistance in current cancer therapy (page 676, conclusion).
These articles plainly demonstrate that the art of developing and testing therapies to treat all types of cancer with compounds of instant claims is unpredictable. More generally, the invention is directed toward medicine and is therefore physiological in nature. It is well established that “the scope of enablement varies inversely with the degree of unpredictability of the factors involved,” and physiological activity is generally considered to be an unpredictable factor. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
4. The amount of direction or guidance provided and the presence or absence of working examples.
The instant claims, directed to a method of treating different types of cancer comprising administering to the subject in need a compound of formula (I) and at least one additional active agent, are extremely broad in contrast with the specification that only provides data, showing therapeutic activity of few compounds (DABK, K5, K6, K7, K8, K9, and K10) on the melanoma (A375, SK-MEL-239-C4 cell lines), colorectal cancer (RKO cell line) and lung adenocarcinoma (A549, CALU6 cell lines). While experimentation is presented for treatment of types of cancer listed above with the compounds recited in experimental examples, the specification does not provide working examples of treatment of any forms of cancer that are not melanoma, colorectal or lung cancer with all the compounds encompassed by formula (I). Although specification provides general directions or guidance of administration regimen, route or dosage e.g.:
the effective amount of compounds or compositions of the disclosure may range from about 0.1 to 100 milligrams (mg) per kilogram (kg) of subject weight (page 25, [0109]);
examples of methods of administration include, but are not limited to, oral administration (e.g., ingestion, buccal or sublingual administration), anal or rectal administration (page 27, [0116]);
the compound of Formula I can be the only active agent administered to a patient or it can be administered together with another active agent (page 27, [0117]),
necessary to treat all of the various cancers encompassed by the claims, the directions are very broad and include vast variety of known formulations. There is no experimentation or mechanism of action presented or discussed in the specification regarding treatment of the cancers that are not melanoma, colorectal or lung cancer. Absence of working examples is a critical factor to be considered, especially in a case involving an unpredictable and undeveloped art. See MPEP 2164.
5. The quantity of experimentation necessary.
Because of the known unpredictability of the art (as discussed supra) and in the absence of experimental evidence commensurate in scope with the claims, the skilled artisan would not accept that all the compounds encompassed by formula (I) are capable of treating all different cancers encompassed by claims. Genentech Inc. vs. Nova Nordisk states, "[A] patent is not a hunting license. It is not a reward for a search but a compensation for its successful conclusion and ‘patent protection’ is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable" (42 USPQ 2d 1001, Fed. Circuit 1997). As noted above, none of the experimentation provided is drawn to the treatment of a cancer that is not a melanoma, colorectal or lung cancer. A review of the state of the art fails to reveal that all possible compounds of formula (I) are useful as a therapeutic for the treatment of all cancers recited by claims, except for a cancers listed above. Determining if any particular claimed compound would treat any particular cancerous disease state would require synthesis of the compound, formulation into a suitable dosage form, and subjecting it to clinical trials or to testing in an assay known to correlate to clinical efficacy of such treatment.
Accordingly, the instant claims do not comply with the enablement requirement of 35 U.S.C. 112(a), since to practice the claimed invention a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 9, 19 and 21 – 23, 25 and 26 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Zhang et al (WO 2014/194127 A1, cited in IDS, filed 02/10/2023, hereinafter Zhang).
Regarding claims 1, 9, 19 and 21, drawn to a compound of formula (I)
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, such as compound K7
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and a pharmaceutical composition thereof, Zhang teaches compound of formula (Ic-1a)
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(page 46,[0121]), such as compound P-2141
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(page 73, Table 1). Zhang further teaches pharmaceutical composition, comprising compound of formula (Ic-1a) (page 114, [0186]). The exemplary compound P-2141, taught by Zhang, has a structure identical to the instantly claimed compound K7, including configuration of stereocenter.
Thus, teachings of Zhang anticipate compound and composition of instant claims.
Regarding claims 22, 25 and 26, drawn to a method of treating a patient suffering from melanoma, lung cancer or colorectal cancer, comprising administering a therapeutically effective amount of a compound of formula (I) or salt thereof to the patient, or wherein the compound of formula (I) or salt thereof is a first active agent and is administered together with at least one additional active agent such as a MEK inhibitor, a CDK4/6 inhibitor or a PI3K inhibitor.
Zhang teaches a method of treating a variety of cancers, such as human melanoma, colorectal and lung cancers comprising administering compound of formula (Ic-1a), e.g. compound P-2141 (page 128, [0223]). Zhang further teaches a method, where compound of formula (Ic-1a) or a pharmaceutically acceptable salt thereof is combined with another pharmacologically active compound, such as one or more therapeutic agents (e.g.: MEK inhibitors, Cdk4 inhibitors, PI3K inhibitors, etc.) (page 134 - 135, [0236]).
Regarding claim 23, drawn to a method of treating a patient suffering from a cancer susceptible to treatment with a RAF inhibitor, comprising administering a therapeutically effective amount of a compound of formula (I) or salt thereof to the patient.
Zhang teaches a method of treating a variety of cancers, where the method includes selectively inhibiting a mutant RAF kinase, such as a mutant BRAF kinase (page 5, [0008]). Method taught by Zhang applies compounds of formula (Ic-1a) (e.g. compound P-2141), which act as RAF inhibitors, by selective inhibition of mutant BRAF protein kinases. Zhang demonstrates effectiveness of compounds on human cancer cell lines with BRAF V600E mutation (A375 melanoma, SKMEL3 melanoma, and COLO205 colon adenocarcinoma (page 126, [0217] and biochemical assays).
Therefore, teachings of Zhang anticipate the compounds and method of instant claims 1, 9, 19 and 21 – 23, 25 and 26.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al (WO 2014/194127 A1, cited in IDS, filed 02/10/2023).
Instant claims are drawn to a compound of formula (I), such as compound K7
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or a pharmaceutically acceptable salt thereof, and a method of treating a patient suffering from a cancer, comprising:
(a) determining that a cell of the cancer contains a BRAFV600E mutation, and
(b) administering a therapeutically effective amount of a compound of formula (I) (e.g. compound K7) or salt thereof.
Zhang teaches compound of formula (Ic-1a)
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(page 46, [0121]), such as compound P-2141
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(page 73, Table 1). Zhang further teaches a method of treating a cancer mediated by a BRAFV600E mutant, or a BRAFV600E/L505H mutant, wherein the method involves administering to the subject in need thereof an effective amount of one or more compound(s) of formula (Ic-1a) (e.g. compound P-2141) (pages 128 [0222] and 131, [0225]). The compounds, used in Zhang’s method act as RAF inhibitors, selectively inhibiting mutant BRAF protein kinases. Zhang demonstrates effectiveness of compounds on human cell lines with BRAF V600E mutation (A375 melanoma, SKMEL3 melanoma, and COLO205 colon adenocarcinoma (page 126, [0217] and biochemical assays).
Although Zhang does not explicitly teach the method where the method comprises determining that a cell of the cancer contains a BRAFV600E mutation, and then administering a therapeutically effective amount of a compound of formula (I), however it is within the level of knowledge of skilled artisan to recognize that if the method is adapted to treat cancer mediated by BRAFV600E mutation, then the mutation must be known, and thus, determined before starting said method of treatment.
Thus, it would be prima facie obvious to one of ordinary skill in the art before effective filing date of the claimed invention to apply teachings of prior art, which teaches a method of treating certain types of cancer mediated by BRAFV600E mutation with compounds selectively inhibiting mutant BRAF protein kinases, to achieve the claimed invention. A person of ordinary skill in the art would have been motivated to do so in search of an improved method of treating cancer mediated by certain mutations to selectively target these mutations with a reasonable expectation of success.
Therefore, taking all together, taught by prior art, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
Claims 1, 9, 19 and 21 – 26 are rejected. No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELENA V VISHNYAKOVA whose telephone number is (571)272-3781. The examiner can normally be reached 7:30am - 5pm ET.
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/E.V.V./ Examiner, Art Unit 1691
/SAVITHA M RAO/ Primary Examiner, Art Unit 1691